What evidence do we need for biomarker qualification?. Leptak, C., Menetski, J. P., Wagner, J. A., Aubrecht, J., Brady, L., Brumfield, M., Chin, W. W., Hoffmann, S., Kelloff, G., Lavezzari, G., Ranganathan, R., Sauer, J., Sistare, F. D., Zabka, T., & Wholley, D. Science Translational Medicine, November, 2017. doi abstract bibtex Biomarkers can facilitate all aspects of the drug development process. However, biomarker qualification-the use of a biomarker that is accepted by the U.S. Food and Drug Administration-needs a clear, predictable process. We describe a multistakeholder effort including government, industry, and academia that proposes a framework for defining the amount of evidence needed for biomarker qualification. This framework is intended for broad applications across multiple biomarker categories and uses.
@article{leptak_what_2017,
title = {What evidence do we need for biomarker qualification?},
volume = {9},
issn = {1946-6242},
doi = {10.1126/scitranslmed.aal4599},
abstract = {Biomarkers can facilitate all aspects of the drug development process. However, biomarker qualification-the use of a biomarker that is accepted by the U.S. Food and Drug Administration-needs a clear, predictable process. We describe a multistakeholder effort including government, industry, and academia that proposes a framework for defining the amount of evidence needed for biomarker qualification. This framework is intended for broad applications across multiple biomarker categories and uses.},
language = {eng},
number = {417},
journal = {Science Translational Medicine},
author = {Leptak, Chris and Menetski, Joseph P. and Wagner, John A. and Aubrecht, Jiri and Brady, Linda and Brumfield, Martha and Chin, William W. and Hoffmann, Steve and Kelloff, Gary and Lavezzari, Gabriela and Ranganathan, Rajesh and Sauer, John-Michael and Sistare, Frank D. and Zabka, Tanja and Wholley, David},
month = nov,
year = {2017},
pmid = {29167393},
keywords = {Animals, Biomarkers, Humans, United States, United States Food and Drug Administration},
}
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